Specialty pharmaceutical company NuPathe has begun dosing patients for NP101-015, a Phase 1 study of ZECUITY (sumatriptan iontophoretic transdermal system) in adolescents with a history of migraine attacks.
An open label, single-dose study, NP101-015 will assess the safety, pharmacokinetics, and tolerability of ZECUITY in adolescent migraine patients. The drug was approved by the FDA in January for the acute treatment of migraine with or without aura in adults. ZECUITY is the first and only FDA-approved patch for treating migraine. The study is part of NuPathe’s post-marketing requirements.
Currently, oral tablets are the only approved administration route for acute treatment of migraine attacks in adolescents. An analysis of the largest survey of migraine sufferers, the landmark American Migraine Prevalence and Prevention Study (AMPP), showed that 5% of boys and 7.7% of girls ages 12 to 19 meet the ICHD-2 criteria for migraine. Adolescents suffer the same basic migraine symptoms as adults, such as headache pain, migraine-related nausea, photophobia, and phonophobia. A retrospective review of Glaxo Wellcome (now GlaxoSmithKlien) adolescent clinical trials database (N = 1,952) shows that 53% of adolescent patients experienced nausea.
The NP101-015 trial will enroll up to 36 adolescent patients, ages 12 to 17, who have a history of acute migraine attacks but are otherwise healthy. There will be a similar number of patients between the ages of 12 and 14 and the ages of 15 to 17, with distribution of both sexes in each age bracket. The study’s primary objectives are to determine the safety and tolerability of a single dose of ZECUITY in adolescent subjects with a history of acute migraine and to determine the pharmacokinetics of sumatriptan in adolescent subjects when delivered by ZECUITY’s transdermal administration route. The study’s results are expected in July 2014.
For more information, visit www.zecuity.com and www.nupathe.com
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